NCT07013929

Spyral InSight Study

Spyral InSight Early Clinical Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.

Detailed description

This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months. There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows: * To assess safety of RNS when performed prior to and post RDN. * To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.

Conditions

• Hypertension
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Renal nerve stimulation	Renal nerve stimulation will be performed prior to and post renal denervation.

Timeline

• Start date: 2025-06-09
• Primary completion: 2027-02-28
• Completion: 2027-07-01
• First posted: 2025-06-10
• Last updated: 2026-04-13

Locations

2 sites across 2 countries: Greece, Ireland